HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic. According to the biotech company, its fully human MAbs have the potential to prevent the spread of the virus by blocking infection of cells.

Through the multiyear collaboration with Mount Sinai Health System, Harbour hopes to explore whether the approach could be used therapeutically for people who have been exposed to the virus, or prophylactically for individuals with a high risk of exposure, such as health care workers.

Jingsong Wang, CEO, Harbour Biomed

“The Harbour Mice platforms can generate fully human MAbs in both conventional IgG and unique 'heavy chain only' antibodies in transgenic mice,” Jingsong Wang, the founder, chairman and CEO of Harbour, told BioWorld. “In these mice, the endogenous antibody-producing genes have been either deleted or inactivated; they can only use the transgenic human antibody genes to produce antibody, which saves significant time and resources.”

The antibodies produced that way are generally considered to be safer and more suitable for human use. That type of technology platforms has become a way to produce high-quality antibodies for drug discovery purposes.

The Harbour Mice platform had successfully generated functional neutralizing antibodies against SARS, MERS and other viruses in previous efforts to treat viral infections. Hence, Wang said he believes it could be used successfully to tackle COVID-19.

“Up-to-date, significant knowledge has been gained on how COVID-19 infects human cells,” he said. “And with the experience we gained in the past on other viruses, we are confident in being able to generate antibodies to neutralize the function of COVID-19 and, thus, treat patients infected by the virus and prevent the infection in high-risk populations such as those with close contact with the patients, including health care workers.”

According to Harbour, its platforms have been validated by more than 200 projects carried out by the company and its partners, with multiple projects having entered clinical trials.

“In addition to the Harbour Mice, we can take advantage of the newly established Beacon optofluidic platform,” said Wang. The platform greatly accelerates the process of antibody discovery by allowing tens of thousands of B cells expressing antigen-specific antibodies to be screened in automated high-throughput fashion within a single day.

Harbour has multiple ongoing programs under this new partnership with Mount Sinai, including the COVID-19 antibody and additional oncology programs.

“Depending on the rate of progression for these programs, we expect to have a lead drug candidate entering preclinical study within the next six to 12 months,” said Wang.

Wang said his company will have the option to license the full rights for clinical development and commercialization of drug candidates derived from these collaborations. Alternatively, it could receive milestones and royalties if the company chooses to work with partners to further develop the programs.

It’s been a busy time for Harbour. At the end of February, the biotech firm completed a phase I study in China for HBM-9161, its fully human anti-FcRn monoclonal antibody.

The trial was conducted to evaluate the drug candidate’s safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Chinese subjects. The results demonstrated an excellent safety profile and potent IgG reduction capability.

Based on the results of the study and data generated by its global partner, Harbour intends to kick off clinical trials this year in several autoimmune diseases for the compound.

“There will be multiple clinical trials carried out in patients in at least four autoimmune indications, including neuromyelitis optical spectrum disease, myasthenia gravis, idiopathic thrombocytopenia, Graves’ ophthalmopathy,” said Wang. “Most of these studies will start in the first half of the year.”

Harbour also received the U.S. FDA’s green light for its IND application for a phase II trial of HBM-9167, a humanized IgG1 MAb targeting PD-L1, for the treatment of nasopharyngeal cancer (NPC).

Separately, HBM-9167 was granted the orphan drug designation for the use in treating NPC. Orphan drug status qualifies Harbour for various development incentives under the Orphan Drug Act, such as eligibility for a seven-year period of market exclusivity following regulatory approval, clinical trial assistance and a 50% tax credit on the cost of clinical trials conducted in the U.S.

Furthermore, Harbour received the U.S. FDA’s approval for the clinical studies of HBM-4003, its next-generation anti-CTLA4 antibody for the treatment of cancer. The U.S. study follows and builds on an ongoing trial in Australia.